Coated VICRYL DC303Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031036185), received between Apr 20, 2022 and Jan 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP APPENDECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THEY WERE CLOSING AN UMBILICAL INCISION AFTER A LAP APPY. THE DR. WAS THE SUTURE AND THE NEEDLE BENT SO HE HANDED IT BACK TO THE WRITER AND ASKED FOR A NEW ONE. THE NEW SUTURE WAS HANDED UP AND WHILE SEWING THE NEEDLE BROKE IN HALF IN THE PATIENT. NINETY MINUTES WERE ADDED TO THE CASE WHILE THEY SEARCHED FOR NEEDLE FRAGMENT. AP AND LATERAL FLAT PLATES WERE DONE TO ASSESS WHERE IN THE ABDOMEN THE NEEDLE WAS. AN X-RAY WAS PERFORMED AND INDICATED IT WAS IN THE MUSCLE/FACIAL LAYER. THE DR. HAD THE IDEA TO USE THE SENTIMAG MACHINE TO HELP LOCATE THE NEEDLE FRAGMENT WHICH WORKED WELL. THEY WERE ABLE TO FIND AND REMOVE THE FRAGMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114140 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. ON THE SURGEON'S LAST PASS, THE NEEDLE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159719 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269. One submission often covers many models, so check the product and lot details in each record.

• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc